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Study Title and Description

Can foods with added soya-protein or fish-oil reduce risk factors for coronary disease? A factorial randomised controlled trial.



Key Questions Addressed
1 RCTs and other Comparative studies
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Primary Publication Information
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TitleData
Title Can foods with added soya-protein or fish-oil reduce risk factors for coronary disease? A factorial randomised controlled trial.
Author Harrison RA., Sagara M., Rajpura A., Armitage L., Birt N., Birt CA., Yamori Y.
Country Bolton Primary Care Trust, UK.
Year 2004
Numbers Pubmed ID: 15853118
15307 (internal)

Secondary Publication Information
There are currently no secondary publications defined for this study.


Extraction Form: Comparative Studies
Arms
Number Title Description Comments
1 DHA food with added DHA; with or without added soya protein
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2 Placebo same food but with no added DHA; with or without added soya protein
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Design Details
Question... Follow Up Answer Follow-up Answer
Study Design Trial: Randomized Factorial Design
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Country in which study conducted (where subjects live) UK
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Funding source Industry only donated materials (eg, supplements)
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Eligibility Criteria: men and women aged 45-59 with a total serum cholesterol >=5.7mmol/l or a mean SBP >= 130 mmHg or both. Exclusions: Those taking existing medications fr blood pressure or cholesterol.
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Comment about Eligibility Criteria: participants randomly selected from 12 general practices on the Islands of Lewis and Harris, whose inhabitants have high cholesterol.
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Study Population Primary Prevention, Increased CVD Risk (ie, diabetes, metabolic syndrome*, hypertension, dyslipidemia, or chronic kidney disease)
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Duration of Intervention 5 weeks
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At baseline, did all subjects have (per eligibility criteria)...? ... Define: Hypertension ... SBP >= 130 mmHg
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Dyslipidemia ... Total cholesterol >= 5.7 mmol/l
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Does the study report a subgroup analysis for an outcome of interest? No
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Study start date(s) 2001
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Baseline Characteristics
Question DHA Placebo Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up
Baseline Diseases/Conditions No data entered.
Baseline characteristics, continuous 52 52
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130.9 134.7
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81.1 81.8
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7.1 6.7
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5.65 mmol/L
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mmol/L 5.0
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1.65 mmol/L
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mmol/L 1.7
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27.4 mmol/L
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27.2
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Male, percent 50.5 54.4
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Race nd
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Comments about baseline data No data entered.
Baseline diet description nd
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Baseline omega-3 intake nd
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Does this study report baseline omega-3 biomarker data? Yes
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Results & Comparisons


Results Data
Outcome: lipid      Population: 45437
Time Point Measure DHA Placebo


0 weeks

N Analyzed 101 112
Mean 1.65 1.65
SE nd nd


5 weeks

N Analyzed 101 112
Mean 1.69 1.63
SE 0.02 0.02
Outcome: lipid      Population: 45438
Time Point Measure DHA Placebo


0 weeks

N Analyzed 101 112
Mean 5.65 4.95
SE nd nd


5 weeks

N Analyzed 101 112
Mean 4.59 4.60
SE 0.06 0.06
Outcome: bp      Population: 45439
Time Point Measure DHA Placebo


0 weeks

N Analyzed 101 112
Mean 81.1 81.8
SE nd nd


5 weeks

N Analyzed 101 112
Mean 76.22 77.95
SE 0.53 0.51
Outcome: bp      Population: 45440
Time Point Measure DHA Placebo


0 weeks

N Analyzed 101 112
Mean 130.9 134.7
SE nd nd


5 weeks

N Analyzed 101 112
Mean 125.79 125.85
SE 1.33 1.16

Adverse Events
Arm or Total Title Description Events (n) At Risk (N) Follow-up time Comments

Quality Dimensions
Dimension Value Notes Comments
Was the allocation sequence (RANDOMIZATION METHOD) adequately generated? LOW
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Was ALLOCATION adequately concealed (prior to assignment)? LOW
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Were PARTICIPANTS adequately BLINDED? LOW
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Were OUTCOME ASSESSORS adequately BLINDED? LOW
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Incomplete outcome data (ATTRITION BIAS) due to amount, nature or handling of incomplete outcome data HIGH 25% loss to followuo
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Is there evidence of SELECTIVE OUTCOME REPORTING bias (Yes/No)? No
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INTENTION-TO-TREAT analysis? (Yes/No) Yes
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Group SIMILARITY AT BASELINE (**GENERAL**) LOW
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Was there incomplete COMPLIANCE with interventions across groups? HIGH 73.6% returned FFQ and had eaten >= 80% of foods. Biomarker data suggests compliance, but only done in 88/159.
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Group SIMILARITY AT BASELINE (**OMEGA-3**) HIGH DHA baseline: DHA group 1.84, placebo group 1.51
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Additional Bias: Bias due to problems not covered elsewhere in the table.
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If outcome assessor blinding risk of bias is different for different outcomes (eg, lipids vs. MI), choose HIGH risk of bias and describe in Notes LOW
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If attrition risk of bias is different for different outcomes (eg, lipids vs. MI) or different time points (eg, 1 year vs. 5 years), choose HIGH risk of bias and describe in Notes HIGH 30% loss in DHA group compared to 19% in placebo group
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Quality Rating
No quality rating data was found.